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OpenTrials
Completed

NCT Number: NCT02319538

Hashimoto - a Surgical Disease. Total Thyroidectomy Makes Antibodies Disappear and Ameliorates Symptoms

The investigators have already proven that absolute total thyroidectomy gives elimination of anti-TPO antibodies. Our hypothesis is that this elimination also eliminates the typical Hashimoto symptoms, namely: Serious tiredness, increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. The prerequisite for this effect is that the total thyroidectomy is meticulously performed. There exists no other treatment that can eliminate the antibodies. The study is randomized between operation and ordinary conservative medical treatment with thyroxine control and supplementation. The symptoms in both groups are evaluated by 5 different Quality of Life schemes, internationally approved.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Telemark Hospital Trust, surgical department

Skien, 3710, Norway

About this study

The study hypothesis is that elimination of anti-TPO antibodies ameliorates the typical Hashimoto symptoms like tiredness,increased need of sleep, pain in musculature and joints and dryness in eyes and mouth. It is necessary that the total thyroidectomy is meticulously performed. We have proven the effect on the antibodies, and we have also proven that the operation procedure can be performed without more complications like recurrent nerve damage and hypocalcemia. Neutrality is secured by randomization done by a neutral institution, laryngoscopy by neutral doctors and instructions filling out the QoL-schemes performed by non-biased study nurses.

The study runs for at least 18 months with controls every 6 months. Blood samples are taken and international approved QoL-schemes are filled in. In addition to the randomised main group a side group of patients fulfilling 2 of the 3 inclusion criteria are followed in parallel in order to elucidate the spontaneous development of the disease and showing critical values of antibodies making the symptoms turn up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred due to typical symptoms, believed to be related to Hashimoto´s disease, but not relieved by thyroxin substitution. Optimal thyroid substitution treatment is already provided.
  • Anti-TPO>1000
  • Hypothyroidism with a need for thyroxin supplementation
  • Written informed consent by the patient - information particularly emphasising and quantifying the risk of complications (e.g. recurrent laryngeal nerve palsy). The patient should be informed by a medical endocrinologist as well as a surgeon.

Exclusion criteria

  • Patients <18 years of age.
  • Pregnancy.
  • Unable to comprehend information adequately to give informed consent.
  • General anaesthesiological contraindications.
  • An unexpected finding of cancer in the surgical group is not a reason for exclusion per se, but this group should be analyzed separately. It is expected that any different loading in Quality of life would bias the medically treated group.

Treatment and study plan

Total thyroidectomy performed

Procedure

Surgery combined with standard thyroxine treatment

Primary outcomes

  1. Better outcome in Quality of Life by operation

    Time frame: 18 months

    The patiens are followed for 18 months with blood samples and filling in Quality of Life schemes every 6 months

Secondary outcomes

  1. Lowering of antibodies (Blood samples)

    Time frame: 18 months

    Blood samples every 6 months

Other outcomes

  1. Safety in performing absolute total thyroidectomy (recurrence nerve and long lasting hypocalcemia)

    Time frame: 12 months

    Safety concerning the recurrence nerve and long lasting hypocalcemia. Interim analysis after 75 patients.

  2. Interim analysis after 75 patients concerning safety (recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples)

    Time frame: 12 months

    The patients operated upon are investigated after 12 months concerning safety. The recurrent nerve control by laryngoscopy and hypocalcemia control by blood samples.

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Collaborators

  • Haukeland University Hospital
  • Helse Stavanger HF

Registry information

Official study title

Surgical Treatment of Hashimotos Disease. Effect on Antibodies and Clinical Symptoms.

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2014
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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